Prior studies have shown that patients receiving phosphatidyl choline experienced a reduction by one-third of the death rate in recovered myocardial infarction cases over a three-year period of time. The anti-antherogenic properties of choline in experimental animals has also been shown. Although not as extensive as the choline studies, it has been found also that phosphatidyl inositol and lecithin demonstrated anti-atherosclerosis and blood plasma or serum liquid lowering efficacy.
Another study demonstrated the "clearing" effect of the phosphatidyl choline upon human coronary, aortic and other connective tissue cells in tissue culture systems. The "clearing" effects of this phosphatidyl choline was demonstrated by the removal of lipids such as cholesterol, beta lipoproteins, triglycerides and related lipoproteins from the arterial tissues of human origin.
Heparatin sulfate has been reported by two groups of investigators as having a significant anti-atherogenic property.
The effectiveness of crude, bovine trachael cartilage for prevention of experimental animal coronary heart disease has been reported. The ingredients in this crude extract include heparatin sulfate, keratan sulfate and chondroitin sulfate B, all mucopolysaccarides.
Silicon as a trace mineral has been reported as having anti-atherogenic properties.
Niacin or nicotinic acid has been demonstrated by numerous investigators in the scientific literature to possess lipid-lowering and anti-antherogenic activities. In a recent study by the National Institutes of Health entitled "The Coronary Drug Project Study", (JAMA, Vol. 231, No. 4, p. 360, Jan. 27, 1975), it was shown that nicotinic acid could reduce the heart attach rate by one-third.
It has also been reported that there was obtained a 74% to 80% clinical improvement in 134 patients with coronary heart disease, cerebral atherosclerosis such as "stroke", and peripheral, ischemic atherosclerotic obstruction of the lower extremities when such patients were treated with calf aorta extract comprising elastomucoproteases enzyme inhibitor.
Clinical improvement and blood cholesterol lowering effect of lecithin has also been described in patients with confirmed coronary heart disease.
The present invention relates to a novel and improved combination of ingredients. Although it is evident that most of the above-described individual ingredients in the combination of the invention have been reported in the scientific literature, no one has ever published such combinations, either in toto or in part for the purposes we employ. The synergy of the above combinations has been proven in the following ways including:
Marked reduction in death rate to zero from fatal myocardial infarction, stroke, and arteriosclerotic complications;
Amelioration of symptoms of angina pectoris;
Reduction in coronary thrombosis, coronary incidents, heart attacks, nonfatal heart attack;
Increase in exercise tolerance;
Increase in protective blood plasma parameters by lowering fibrinogen, cholesterol, triglycerides, beta lipoproteins, VLDL, LDL, ESR, and increasing the protective HDL; and
Increase in well-being.
More generally, the novel combination of this invention shows the safety and efficacy against atherosclerotic complications of coronary artery disease, cerebrovascular disease such as stroke, peripheral ischemic obstructive athero-arteriosclerosis of the lower extremities, cerebrovascular symptoms such as dizziness (vertigo), and intermittent claudication (pains in legs while at rest or during walking), and related disorders.